Evaluation of Use of Plastic Bags to Prevent Neonatal Hypothermia-Part IV

Hypothermia Clinical Trial

Official title:

Randomized Evaluation of the Use of Plastic Bags to Prevent Neonatal Hypothermia in Developing Countries-Part IV

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01604447
• Other study ID #: UAB Neo 009
• Status: Completed
• Phase: Phase 4
• First received: May 21, 2012
• Last updated: February 23, 2015
• Start date: June 2012
• Est. completion date: February 2015

Study information

• Verified date: February 2015
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardZambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The overall hypothesis is that plastic bags used in combination with WHO thermoregulation care will reduce the incidence of hypothermia in preterm/low birth weight and full term infants when compared to routine WHO thermoregulation care alone. Part V is comparing use of a plastic torso wrap to no plastic torso wrap in preterm/low birth weight infants following removal from their incubator to assist with temperature regulation.

Description:

Due to limited resources and numbers of incubators, hospitals in developing countries remove infants from incubators at lower weights than in developed countries, putting infants at increased risk for hypothermia. This study will compare the incidence of hypothermia during the 72 hours after incubator removal of infants randomized to receive standard incubator removal (control group) or standard incubator removal with a plastic bag covering their torsos and lower extremities (intervention group). The axillary temperature of each infant will be taken upon removal from the incubator, every subsequent 6-8 hours, and finally, at 72 hours as the bags are removed. Blood pressure, blood sugar, seizures, weight gain, hyperthermia, death, observation for respiratory distress, bronchopulmonary dysplasia, sepsis, intraventricular hemorrhage, periventricular leukomalacia, necrotizing enterocolitis, intestinal perforation, pulmonary hemorrhage room temperature and humidity, and length of time in an incubator will be recorded throughout their hospitalization for all infants. With an estimated hypothermia incidence of 30% and a hypothesized 20% absolute risk reduction (66% relative risk reduction), a sample size of 118 will be used to have a power of 80% and a confidence interval of 95%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 72 Hours

Eligibility

Inclusion Criteria:

• Infant admitted to the NICU

• Current weight less than 2,000g

• Being removed from incubator

Exclusion Criteria:

• Abdominal wall defect or myelomeningocele

• Major congenital anomalies

• Blistering skin disorder

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypothermia

Intervention

Procedure:
• Hypothermia prevention with plastic bag
Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
• Hypothermia prevention without plastic bag
Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.

Locations

Country	Name	City	State
Zambia	University Teaching Hospital	Lusaka

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Childrens of Alabama

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Axillary temperature 36.5-37.5 degrees Celsius	Temperature taken per axilla for one minute	1-72 hours	Yes
Secondary	Blood pressure	Measure of extremity blood pressure per cuff taken during nursery stay	Up to 4 weeks	Yes
Secondary	Blood glucose	Measure of blood glucose per laboratory value taken per heel stick	Up to 4 weeks	Yes
Secondary	Seizure	Seizure activity diagnosed by medical doctor or nurse. No electoencephalogram will be done.	Up to 4 weeks	Yes
Secondary	Weight gain	Infant will be weighed daily and rates of weight gain will be calculated	Up to 4 weeks	Yes
Secondary	Respiratory Distress Syndrome (RDS)	Documentation of increased work of breathing, retractions, and a need for oxygen, intubation, or surfactant	Up to 4 weeks	Yes
Secondary	Bronchopulmonary Dysplasia (BPD)	Oxygen requirement at 28 days of life	28 days after birth	Yes
Secondary	Pneumothorax	Either chest radiograph documentation or clinical deterioration consistent with air leak	Up to 4 weeks	Yes
Secondary	Sepsis	Culture proven or culture negative clinically treated course consistent with sepsis	Up to 4 weeks	Yes
Secondary	Major brain injury	Intracranial hemorrhage grade 3-4 or periventricular leukomalacia documented on cranial ultrasound	Up to 4 weeks	Yes
Secondary	Necrotizing enterocolitis or intestinal perforation	Documentation of pneumatosis or intestinal perforation on x-ray or treatment course for clinical necrotizing enterocolitis per Bell's Classification stage greater than 1.	Up to 4 weeks	Yes
Secondary	Pulmonary hemorrhage	Blood seen in the endotracheal tube and treated by physician	Up to 4 weeks	Yes
Secondary	Death	Cardiorespiratory failure	Up to 4 weeks	Yes
Secondary	Hyperthermia	Axillary temperature > 38 degrees Celsius per temperature taken per axilla for 1 minute	Up to 4 weeks	Yes
Secondary	Length of time in incubator	Documentation of length of time spent in incubator and number of times placed in incubator	Up to 4 weeks	Yes
Secondary	Room temperature and humidity	A recording of the room temperature and humidity will be obtained with each axillary temperature measurement	1-72 hours	Yes
Secondary	Incubator temperature and humidity	A recording of the air temperature and humidity with the incubator will be obtained with each axillary temperature measurement	1 hour	Yes